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Trial Title:
Contributions to Hypertension With Androgen Deprivation Therapy
NCT ID:
NCT05700903
Condition:
Androgen Deprivation Therapy
Prostate Cancer
Hypertension
Autonomic Dysfunction
Renal Disease
Conditions: Official terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Hypertension
Leuprolide
Goserelin
Flutamide
Bicalutamide
Hormones
Androgens
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Gonadotropin Releasing Hormone Agonists (GNRH)
Description:
8 weeks of GnRH agonist
Arm group label:
Healthy + ADT
Arm group label:
Prostate Cancer
Other name:
Leuprolide
Other name:
Goserelin
Intervention type:
Drug
Intervention name:
Androgen receptor (AR) inhibitor
Description:
2 weeks of AR Inhibitor
Arm group label:
Healthy + ADT
Arm group label:
Prostate Cancer
Other name:
Bicalutamide
Other name:
Flutamide
Other name:
Enzalutamide
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo tablet and injection
Arm group label:
Healthy + Placebo
Summary:
This study plans to learn more about contributors to high blood pressure in men who
undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is
the most common non-skin cancer in men, affecting approximately 1 in 8 American men and
its primary treatment is through the use of ADT. However, ADT increases the likelihood of
developing heart disease including high blood pressure. This study will determine if
dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these
systems play a significant role in control of blood pressure. The results from this study
will help us understand the ways in which ADT contributes to heart disease and help us
develop therapies to prevent heart disease in prostate cancer survivors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- -age 40+ years;
- resting blood pressure <140/90 mmHg;
- fasted blood glucose <126 mg/dL;
- testosterone ≥400 ng/dL;
- sedentary to recreationally active;
- nonsmokers;
- healthy as determined by medical history, physical exam, blood and urine chemistries
and resting and exercise ECG during a physician supervised graded exercise treadmill
test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo
androgen deprivation therapy;
- PSA <4.00 ng/dL if in the non-cancer group;
- Gleason Score ≤7 if in the prostate cancer group;
- no use of medications that might influence cardiovascular function (e.g.,
antihypertensives, lipid-lowering medications);
- willing and able to be on GnRHagonist and AR inhibitor;
- not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications,
or willing to stop use for four weeks prior to the start of the study;
- not using exogenous sex hormones for at least one year
Exclusion Criteria:
- -acute liver disease;
- chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g of
proteinuria
- pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure
disorder;
- diabetes, active or chronic infection, disease that affects the nervous system;
- Gleason Score ≥8;
- thyroid dysfunction, defined as ultrasensitive TSH <0.5 or >5.0 mU/L, volunteers
with abnormal TSH values will be re-considered for participation after follow-up
evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
- tobacco use within the previous 12 months
Gender:
Male
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UCHealth University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Babcock, PhD
Phone:
720-848-6470
Email:
matthew.babcock@cuanschutz.edu
Investigator:
Last name:
Matthew Babcock, PhD
Email:
Principal Investigator
Start date:
September 20, 2023
Completion date:
March 31, 2028
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700903
